The NEJM published a recent article on the CMS approval of certain new medical technologies. The authors state:
In deciding whether to pay for new medical technologies, the Centers for Medicare and Medicaid Services (CMS) is becoming more specific about its requirements for evidence of improved health outcomes in the Medicare population. In our view, this is a positive and overdue step, but one whose rationale and likely consequences must be better understood by the medical community, policymakers, and the public. Expansions of access to health insurance under the health care reform legislation pending in Congress — and resulting financial pressures — would almost certainly intensify the emphasis on more relevant and robust evidence....
Over time and in fits and starts, Medicare has embraced this emphasis on “outcomes.” The program pays for broad categories of health care services (e.g., hospital and physicians’ services) but is prohibited by law from paying for items and services that are not “reasonable and necessary.” Although most coverage decisions are made by the regional health plans that administer the Medicare program, the CMS issues national coverage determinations (NCDs) each year for 10 to 15 technologies that are projected to have a major impact on care, for which an existing national policy requires updating, or for which regional policies are conflicting.
The NCD or national coverage outcome is the approach of evaluating whether Medicare will reimburse for certain technologies. For example this applies to robotic surgery for psoate cancer. There is currently a paucity of evidence that the robotic approach increases life span yet it does reduce certain morbidities.
They continue:
Some physicians may be concerned about stricter evidentiary requirements, perceiving them as impeding access to important medical advances. Others may be disturbed by the idea of interference by “big government” in the doctor–patient relationship. Still others may suspect the motives underlying the requirement for evidence reviews, seeing the trend as part of a cost-containment agenda, as highlighted recently by the second-guessing of the motives behind changes to the screening guidelines for breast cancer and cervical cancer.
Yes indeed there is this concern and perhaps this was a key element in the recent Massachusetts Senate race outcome. The breast cancer decision was a political disaster. The team making it was apparently devoid of disease specific expertise. Furthermore it was devoid of essential patient input. For it is not just the test per se but the "ritual" of the patient and physician contact which is key. This ritual effort along with the elements of the rituals including mammographies, PSA tests and the like, afford substantial benefit, well beyond just the Government defined end points.
The authors continue:
How do evidence requirements vary among different categories of technology, and how can that evidence be generated most efficiently? When can Medicare make reasonable inferences from studies undertaken in non-Medicare populations? When is it reasonable to extrapolate from surrogate markers studied in randomized, controlled trials to longer-term outcomes? When and how should observational data and other nonexperimental evidence be used? When should technology be reassessed in light of new information?
Part of the solution will come from having a more transparent, timely, and participatory process, and Congress and the CMS have worked to improve matters in this regard. Part of the solution will also come from smarter design and implementation of clinical trials and better synthesis of evidence. The CMS should continue to explore ways to enact flexible coverage policies in order to tie payment to outcomes. The agency has experimented with a policy of “coverage with evidence development,” which enables Medicare to cover the use of promising technologies for patients enrolled in studies that will better determine a technology’s risks and benefits.
The problem is that if CMS demands evidence for any and all treatments then this becomes the chicken and egg problem. The arguments over CCE in the most recent health care bills are prime examples of the concern here. CMS has the authority already to enact many forms of control. It will be interesting to see if CMS does to health care what EPA has done to CO2 control, by fiat!
In deciding whether to pay for new medical technologies, the Centers for Medicare and Medicaid Services (CMS) is becoming more specific about its requirements for evidence of improved health outcomes in the Medicare population. In our view, this is a positive and overdue step, but one whose rationale and likely consequences must be better understood by the medical community, policymakers, and the public. Expansions of access to health insurance under the health care reform legislation pending in Congress — and resulting financial pressures — would almost certainly intensify the emphasis on more relevant and robust evidence....
Over time and in fits and starts, Medicare has embraced this emphasis on “outcomes.” The program pays for broad categories of health care services (e.g., hospital and physicians’ services) but is prohibited by law from paying for items and services that are not “reasonable and necessary.” Although most coverage decisions are made by the regional health plans that administer the Medicare program, the CMS issues national coverage determinations (NCDs) each year for 10 to 15 technologies that are projected to have a major impact on care, for which an existing national policy requires updating, or for which regional policies are conflicting.
The NCD or national coverage outcome is the approach of evaluating whether Medicare will reimburse for certain technologies. For example this applies to robotic surgery for psoate cancer. There is currently a paucity of evidence that the robotic approach increases life span yet it does reduce certain morbidities.
They continue:
Some physicians may be concerned about stricter evidentiary requirements, perceiving them as impeding access to important medical advances. Others may be disturbed by the idea of interference by “big government” in the doctor–patient relationship. Still others may suspect the motives underlying the requirement for evidence reviews, seeing the trend as part of a cost-containment agenda, as highlighted recently by the second-guessing of the motives behind changes to the screening guidelines for breast cancer and cervical cancer.
Yes indeed there is this concern and perhaps this was a key element in the recent Massachusetts Senate race outcome. The breast cancer decision was a political disaster. The team making it was apparently devoid of disease specific expertise. Furthermore it was devoid of essential patient input. For it is not just the test per se but the "ritual" of the patient and physician contact which is key. This ritual effort along with the elements of the rituals including mammographies, PSA tests and the like, afford substantial benefit, well beyond just the Government defined end points.
The authors continue:
How do evidence requirements vary among different categories of technology, and how can that evidence be generated most efficiently? When can Medicare make reasonable inferences from studies undertaken in non-Medicare populations? When is it reasonable to extrapolate from surrogate markers studied in randomized, controlled trials to longer-term outcomes? When and how should observational data and other nonexperimental evidence be used? When should technology be reassessed in light of new information?
Part of the solution will come from having a more transparent, timely, and participatory process, and Congress and the CMS have worked to improve matters in this regard. Part of the solution will also come from smarter design and implementation of clinical trials and better synthesis of evidence. The CMS should continue to explore ways to enact flexible coverage policies in order to tie payment to outcomes. The agency has experimented with a policy of “coverage with evidence development,” which enables Medicare to cover the use of promising technologies for patients enrolled in studies that will better determine a technology’s risks and benefits.
The problem is that if CMS demands evidence for any and all treatments then this becomes the chicken and egg problem. The arguments over CCE in the most recent health care bills are prime examples of the concern here. CMS has the authority already to enact many forms of control. It will be interesting to see if CMS does to health care what EPA has done to CO2 control, by fiat!
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